Senior Research and Development Engineer

About EMED Technologies Corporation

EMED Technologies is an industry leader in the design, manufacture, and distribution of cutting-edge medical devices. For two decades, EMED Technologies has worked with clinicians, inventors, and medical companies to develop innovative medical products. Today, we are proud that both patients and clinicians can benefit from the fruits of our labor because we offer a wide variety of products and services that improve therapies and enhance clinical benefits. Also, with our dynamic team of professionals, EMED continues to work with clinicians to understand their requirements and improve upon available technologies, and we are confident that these endeavors will benefit generations to come In addition to novel technology, EMED is proud to offer licensing agreements for patented and proprietary technologies.

About the role

• The Senior Research and Development Engineer works as part of a cross functional team and is responsible for preparing conceptual ideas and converting them into medical device design requirements and finished product specifications. The Research and Development Engineer supports both new product introduction and sustaining of existing products.
• This position reports to the Director of R&D and Engineering.

What you'll do

• Generates and assists with creation of Project Plans, Device Design and Development Plans, and Design Change Plans.
• Prepares conceptual ideas, sketches, and design concepts. Converts these into medical device user needs and design requirements including device features and benefits. Designs the medical device using CAD/CAE/FEA engineering software tools.
• Creates design documentation that defines form, fit, and function of new products, components, and materials to meet design criteria.
• Coordinates and communicates with external resources and companies to complete project deliverables (e.g., contract manufacturing and outsourcing of deliverables).
• Develops and tests prototypes including collecting and analyzing data and generating reports.
• Performs and assists with verification and validation of design requirements by creating verification protocols, performing tests, and creating reports.
• Performs and assists with usability engineering (human factors) testing of medical devices per IEC 62366
• Prepares, approves, and maintains device design history and development records.
• Assists in preparing documentation for product related regulatory submissions, registrations, and certifications with regulatory bodies in the US, Canada, Europe, and other countries as needed.
• Works with QA/RA to ensure compliance of design and manufacturing process within ISO 13485, 21 CFR 820 and applicable international regulations and standards such as IEC 60601 as needed.
• Performs and assists with risk management activities per ISO 14791.
• Conducts research to solve clinical goals using various means to collate the necessary information, including questionnaires, interviews, and group conferences.
• Assists and performs design cost analysis and optimization to ensure economic viability.
• Assists in identifying and preparing manufacturing processes and approval of manufacturing validation protocols and reports.
• Assists in transfer and implementation of manufacturing processes from R&D to Operations and Manufacturing.
• Reviews and approves Change Orders for Engineering when necessary.
• Evaluates and optimizes procedures and tools to enhance R&D Department's capabilities to develop new products, including the use of multiple external resources.
• Mentors and guides junior engineers, fostering a culture of continuous learning and development.
• Other assignments may be assigned as needed.
• Ensure that all Engineering Department related tasks and responsibilities defined in EMED Quality Management System Documentation are performed, as defined

• Bachelor of Science degree in Mechanical Engineering or equivalent field.
• Four or more years of design experience. Experience with prototyping, testing, analysis, and manufacturing.
• Skills required include communicating with other team members and external companies, technical writing, documentation, and proficient in general computer skills including Word, Excel, PowerPoint, email communication, and CAD 3D/2D software tools.